Pilot Study of Tethered Capsule Endomicroscopy Imaging of the Esophagus Using a Compact Optical Frequency Domain Imaging System

What this Trial Is About

Researchers are evaluating a new tethered capsule endomicroscopy TCE imaging system designed to capture detailed images of the esophagus using optical frequency domain imaging OFDI. This pilot study includes healthy volunteers and participants diagnosed with Barretts Esophagus BE to assess the safety, ease of use, and feasibility of this compact imaging technology in preparation for a larger clinical trial. The study involves inserting a small capsule attached to a string-like tether into the esophagus. The tether allows the operator to control and guide the capsule as it moves down the esophagus via natural swallowing motions. Imaging is performed in real time using the compact OFDI system, and the images are later analyzed to evaluate the devices performance. Participants will undergo imaging sessions lasting about 5 to 7 minutes. The study team will assess the quality and performance of the compact imaging system during this period. Participants must avoid solid food for 4 hours and only consume clear liquids for 2 hours before the procedure. The total participation duration and follow-up details are based on the imaging and safety assessments conducted during the study.

Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System